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A proposal by the Centers for Medicare and Medicaid Services (CMS) to allow individuals with a bachelor of science in nursing to perform moderate- and high-complexity testing has set off a firestorm of debate.     

“A bachelor of nursing degree is not equivalent to the scientific training that laboratory professionals receive,” says Matt Schulze, ASCP Director of Public Policy. “ASCP has vigorously fought this proposal, advocating on behalf of the laboratory community and for quality patient care. We have also engaged our members in this effort.” 

Why this issue is critical
“It’s one thing if we are talking about nurses doing waived, point of care testing, which under the Clinical Laboratory Improvement Amendment regulations don’t require any specific education,” explains Mr. Schulze. “But this proposal means nurses could even perform high complexity molecular testing, and CMS is saying nurses should be allowed to perform these tests based on their current degree. In addition, these nurses are doing point-of-care testing in settings where they are not under the supervision of a laboratory director. And, they may be doing some point-of-care tests that are of moderate or high complexity. But unless they have the right kind of education and training, they should not be allowed to do high complexity testing.” 

CMS has proposed to allow nurses to perform moderate- and high-complexity testing in part to address the workforce shortage. However, with nursing also suffering from serious shortages, this strategy not only seems poised to exacerbate nursing shortages, but to create quality problems for patient testing. Additionally, there are many providers, including nurses, who currently want to expand their scope of practice. Mr. Schulze surmises that while nurses are seeking to perform more complex testing, they may not be fully aware of the level of academic work or upper-level science training that laboratory professionals receive to be able to perform these tests, nor aware of the impact of the tests’ complexity.  

This debate began in 2016 when CMS outlined in a memo to state and regional directors of the Clinical Laboratory Improvement Amendments (CLIA) that nurses could perform moderate- and high-complexity testing, but did not specify what degree was required. In a written response, ASCP voiced its dissent and requested a meeting with CMS leadership. CMS responded that its decision reaffirmed an existing, yet unwritten policy and that the new rule was intended to make CMS more transparent about the policy.  

At that point, ASCP launched a campaign, urging members to sign a petition stating that the proposed rule constituted bad public policy and was harmful to patients. The campaign garnered 35,000-plus signatures, which ASCP then presented to CMS. 

“We hoped, with such a successful the successful petition drive, that CMS would not go forward with the rule. That wasn’t the case,” Mr. Schulze says.  

In 2018, CMS issued a request for information on whether a bachelor of science in nursing constituted training similar to that required for laboratory professionals who performed moderate- to high- complexity testing. ASCP responded in a lengthy comment letter signed by all ASCP BOC BOG sponsoring organizations. The Society also deployed an Action Alert and launched a grassroots campaign urging members and others to flood CMS’ online portal with messages decrying the proposal as unsafe for patient care. Overall, 8,700 letters were submitted, the vast majority in opposition to CMS’ proposed rule. Eight thousand letters were from ASCP members and another 500+ came from members of the American Society for Clinical Laboratory Science (ASCLS).  

Likewise, in November 2018, the Centers for Medicare and Medicaid Services provided a presentation on CLIA’s personnel requirements to the Clinical Laboratory Improvement Advisory Committee (CLIAC), which provides expert advice to the federal agencies with oversight under CLIA. CMS had likely been seeking confirmation that a bachelor of science in nursing would be sufficient to allow nurses to perform moderate- to high-complexity testing. Again, ASCP voiced its opposition on the grounds that it could be harmful to quality patient care.  

Subsequently, CLIAC formed a work group, chaired by ASCP Past President Lee Hilborne, MD, PhD, FASCP, DLM(ASCP)CM, to determine whether a bachelor of science in nursing offered sufficient training to allow the degree holder to perform moderate to complex testing.  

The Society offered its own suggestion of training that would provide a degree equivalency route in order to recognize those who held degrees and had completed 30 hours or more of science training. The work group proposed to the full CLIAC group that alternative degrees (to what was listed in the regulations) could be accepted, based on a certain credit-hour requirement, but didn’t specify how many credit hours should be required. 

“We also wanted personnel standards for histotechnology professionals, since the CLIA personnel rules are silent on the education and training of the complex work they do,” Mr. Schulze recalls. Histotechnology is the only non-waived segment of laboratory testing for which there are no personnel standards. 

Three years ago, CLIAC decided that a bachelor of science in nursing alone was not sufficient to qualify nurses to perform moderate- and high-complexity testing. CMS offered no response at the time. However, earlier this summer, the Agency forwarded a new proposed rule to the federal Office of Management and Budget. The rule proposed changes to CLIA’s personnel requirements as well as changes to CLIA’s fees, histocompatibility rules, and alternative sanctions for Certificate of Waiver laboratories. At that time, it offered a 30-day period for public comment, not the usual 60-day comment period.  

Mr. Schulze surmises, “There is no explanation from the Agency as to why the initial 30-day comment period. My guess is that they did not want to allow a lot of time for opponents of the rule to mobilize the community against it.” 

ASCP pulled together a letter that had support from 22 organizations, including the American Medical Association, The Joint Commission, the Association of Public Health Laboratories, and the American Society for Microbiology, requesting an extension of the public comment period. The day before the comment period was to end, CMS agreed to extend the comment period by another 30 days. 

While awaiting CMS’ response, ASCP continued to manage a grassroots campaign, urging members and others to voice their opposition to the rule. When the 60-day comment period had ended, more than 20,000 comments had been submitted to CMS, with most coming from the ASCP eAdvocacy portal.  

“Ninety-nine percent of all the comments CMS received were generated by ASCP’s Advocacy campaign,” Mr. Schulze recalls. “We said, in a deafening way, that a bachelor of science in nursing is not sufficient for someone to perform moderate- and high-complexity testing. There are point-of-care tests that are high complexity, and CMS has argued that the majority of point-of-care testing is done by nurses. However, CMS seems to be referring to waived tests, and there are no degree requirements in order to administer waived tests. The CLIA definition of waived tests is that they are so simple that they should be easy to do and should not pose harm to patient.” 

CMS had hoped to get the rule published online this fall; however, it’s unclear when a final regulation will be released. 

Despite the many hurdles ASCP encountered in challenging CMS’ plan to allow nurses to administer high complexity testing, Mr. Schulze maintains, “This is a story of our victory for the laboratory. While I don’t know if CMS will change its mind on this, ASCP had a huge response from our members and really got them engaged in this advocacy effort.” 

To reiterate what ASCP BOC Executive Director Amy Spiczka said earlier, with this much energy revved up on the part of ASCP members and the laboratory community, ASCP is on a roll. There is much more advocacy to come.

ASCP Eyes Advocacy Priorities for the Year Ahead 

As ASCP and the ASCP Board of Certification (BOC) look ahead to 2023, they will focus on the following priorities: